Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium

March 17, 2022 updated by: Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital
The investigators are performing this research study to understand the role of sleep disturbance on the incidence/severity of delirium after surgery. The investigators will study the brain using a polysomnography device (PSG), which records the brain's electrical activity during sleep.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During this study, PSG recordings will be collected and a sleep questionnaire will be administered to participants on the night before surgery in order to establish level of preexisting sleep disturbance. Delirium assessments will be conducted during the postoperative period. On postoperative days 0 and 1, blood will be collected for analysis. Further cognitive, quality of life and pain questionnaires will be administered perioperatively.

Study Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Inpatients over the age of 60 scheduled for a surgical procedure at MGH

Description

Inclusion Criteria:

  • Over 60 years of age
  • Inpatient and scheduled for surgical procedure at MGH

Exclusion Criteria:

  • Blindness, deafness or the inability to speak English
  • Inability to provide informed consent

Objective Drop Criteria

  • Post-operative intubation greater than 24 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MGH Surgery Patients
PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH.
Device: PSG
PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association Between Sleep and POD
Time Frame: Night before surgery, approximately 13 hours
Duration of sleep in delirious vs non-delirious patients
Night before surgery, approximately 13 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Burst Suppression Ratio
Time Frame: Length of surgery (2-12 hours)
Burst suppression ratio during cardiopulmonary bypass. EEG recordings from the operating room were collected and analyzed for burst suppression.
Length of surgery (2-12 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

April 5, 2018

First Submitted That Met QC Criteria

April 12, 2018

First Posted (Actual)

April 13, 2018

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 17, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018P000480

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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